CHIKV

Bavarian Nordic’s Chikungunya Vaccine Candidate Granted Accelerated Assessment by European Medicines Agency

Retrieved on: 
Friday, February 23, 2024
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Bavarian Nordic is on track to submit its Marketing Authorisation Application for CHIKV VLP to EMA during H1 2024.

Key Points: 
  • Bavarian Nordic is on track to submit its Marketing Authorisation Application for CHIKV VLP to EMA during H1 2024.
  • COPENHAGEN, Denmark, February 23, 2024 – Bavarian Nordic A/S (OMX: BAVA) (“the Company”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated assessment for the upcoming Marketing Authorisation Application (MAA) for CHIKV VLP, the Company’s investigational chikungunya vaccine.
  • Bavarian Nordic is on track and plans to submit its MAA for CHIKV VLP to the EMA during H1 2024.
  • “We are pleased to receive the accelerated assessment in recognition of our chikungunya vaccine candidate and our efforts to bring this novel product to the market.

Emergex Signs Contract of £1.79M with the UK Department of Health and Social Care’s UK Vaccine Network (“UKVN”) to Advance Its Novel Synthetic T Cell-Priming Set-Point Candidate Against Chikungunya Virus

Retrieved on: 
Friday, November 17, 2023
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In the last decade, CHIKV has become a reemerging mosquito-transmitted virus that has spread into Europe, Asia, the Pacific Region, and the Americas, with epidemics causing severe economic impact.

Key Points: 
  • In the last decade, CHIKV has become a reemerging mosquito-transmitted virus that has spread into Europe, Asia, the Pacific Region, and the Americas, with epidemics causing severe economic impact.
  • The programme is intended to position Emergex for entry to the clinic by its completion, ready to begin a Phase-1 clinical trial.
  • Subsequently, Emergex achieved all milestones priming the CHIKV candidate for progression to the next stage of its preclinical development.
  • A Phase-2 trial for CoronaTcP and a Phase-1 trial for a Universal Influenza vaccine candidate are planned in H1 2024.

Valneva Reports Positive Pivotal Phase 3 Immunogenicity Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate

Retrieved on: 
Monday, November 13, 2023
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Saint-Herblain (France), November 13, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive pivotal Phase 3 immunogenicity data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553.

Key Points: 
  • Saint-Herblain (France), November 13, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive pivotal Phase 3 immunogenicity data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553.
  • These results complement the initial Phase 3 safety data the Company reported for the trial in August 20231.
  • The pivotal immunogenicity data showed that a single-dose vaccination with VLA1553 induced a robust immune response in adolescents aged 12 to
  • An independent Data Safety Monitoring Board has continuously evaluated safety data during the trial and has not identified any safety concerns.

Valneva Announces U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ®

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Friday, November 10, 2023
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Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.

Key Points: 
  • Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.
  • As sponsor of the first chikungunya vaccine approved in the U.S., Valneva has received a Priority Review Voucher (PRV) from the FDA, which it intends to monetize to help finance its research and development (R&D) programs.
  • With this U.S. approval, IXCHIQ® becomes the world’s first licensed chikungunya vaccine available to address this unmet medical need and the third vaccine Valneva1 has brought from early R&D to approval.
  • Initial safety data from this trial were included in the submission to the European Medicines Agency (EMA) in October 202313.

Valneva Submits Chikungunya Vaccine Marketing Application to EMA and Announces CHMP Accelerated Assessment

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Wednesday, October 25, 2023
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Saint-Herblain (France), October 25, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the submission of a marketing application with the European Medicines Agency (EMA) for approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553.

Key Points: 
  • Saint-Herblain (France), October 25, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the submission of a marketing application with the European Medicines Agency (EMA) for approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553.
  • Valneva was also granted accelerated assessment1 for the application by EMA’s Committee for Medicinal Products for Human Use (CHMP) based on the vaccine candidate’s “major interest for public health and therapeutic innovation”.
  • VLA1553 is currently the first and only chikungunya vaccine candidate worldwide for which regulatory review processes are underway.
  • Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “We welcome EMA’s accelerated assessment and will work closely with them to bring this vaccine to market.

Valneva to Present on Chikungunya at Several Leading Scientific Conferences

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Wednesday, October 11, 2023
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Saint-Herblain (France), October 11, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today it will present on the mosquito-borne chikungunya disease at several leading scientific conferences during the fourth quarter of 2023.

Key Points: 
  • Saint-Herblain (France), October 11, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today it will present on the mosquito-borne chikungunya disease at several leading scientific conferences during the fourth quarter of 2023.
  • At IDWeek, the annual meeting of the Infectious Diseases Society of America (IDSA), Valneva will support the roundtable discussion “Chikungunya is an Increasing Global Threat: The Need for Better Protection” taking place on October 14, 2023 at 6:00 pm Eastern Daylight Time (EDT) in Boston, Massachusetts.
  • At the American Society of Tropical Medicine and Hygiene (ASTMH) 2023 Annual Meeting in Chicago, Illinois, Valneva will hold two chikungunya presentations on October 20, 2023 at 11:00 am and 12:15 pm Central Daylight Time (CDT).
  • At the International Society of Vaccines Annual Congress taking place in Lausanne, Switzerland Valneva will present on chikungunya on October 24, 2023 at 09:45 am Central European Summer Time (CEST).

Valneva Reports Positive Initial Phase 3 Safety Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate

Retrieved on: 
Monday, August 28, 2023
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Saint-Herblain (France), August 28, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive initial Phase 3 safety data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553.

Key Points: 
  • Saint-Herblain (France), August 28, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive initial Phase 3 safety data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553.
  • An independent DSMB has continuously evaluated safety data during the trial and has not identified any safety concerns.
  • Importantly, the initial data suggest a favorable safety profile in seropositive participants, confirming the observations following re-vaccination of individuals in Phase 1 trial VLA1553-1011.
  • If approved, VLA1553 could become the first licensed chikungunya vaccine available to address this unmet medical need.

Bavarian Nordic Reports Positive Phase 3 Topline Results for Chikungunya Virus Vaccine in Adults and Adolescents

Retrieved on: 
Sunday, August 6, 2023
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COPENHAGEN, Denmark, August 6, 2023 – Bavarian Nordic A/S (OMX: BAVA) announced today positive topline results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial ( NCT05072080 ) of its virus-like particle (VLP)-based chikungunya virus vaccine candidate, CHIKV VLP (PXVX0317) in adults and adolescents aged 12 to 64 years of age.

Key Points: 
  • COPENHAGEN, Denmark, August 6, 2023 – Bavarian Nordic A/S (OMX: BAVA) announced today positive topline results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial ( NCT05072080 ) of its virus-like particle (VLP)-based chikungunya virus vaccine candidate, CHIKV VLP (PXVX0317) in adults and adolescents aged 12 to 64 years of age.
  • A total of 3,254 participants were enrolled and randomized to receive either a single intramuscular injection of CHIKV VLP, or placebo.
  • “We are highly encouraged by the positive topline results now demonstrated in both Phase 3 studies of our chikungunya vaccine candidate.
  • “With a fast and durable response, our vaccine has the potential to be the best in class to prevent chikungunya infections in adolescents to elderly adults.

Bavarian Nordic Reports Data from a Phase 3 Clinical Trial of its VLP-Based Chikungunya Virus Vaccine in Adults ≥65 Years of Age

Retrieved on: 
Tuesday, June 20, 2023
VLP, OMX, Bavarian Nordic, Vaccination, Chikungunya, Safety, CHIKV, Vaccine

COPENHAGEN, Denmark, June 20, 2023 – Bavarian Nordic A/S (OMX: BAVA) announced today the initial safety and immunogenicity results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial of a virus-like particle (VLP)-based chikungunya virus (CHIKV) vaccine candidate CHIKV VLP (PXVX0317) in healthy adults ≥65 years of age.

Key Points: 
  • COPENHAGEN, Denmark, June 20, 2023 – Bavarian Nordic A/S (OMX: BAVA) announced today the initial safety and immunogenicity results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial of a virus-like particle (VLP)-based chikungunya virus (CHIKV) vaccine candidate CHIKV VLP (PXVX0317) in healthy adults ≥65 years of age.
  • Results from a second Phase 3 study evaluating the safety and immunogenicity of CHIKV VLP in healthy adolescents and adults 12 to 64 years old will report data during the third quarter of 2023.
  • A total of 413 participants were enrolled and randomized 1:1 to receive either a single intramuscular injection of CHIKV VLP or placebo.
  • They also match what has previously been reported for younger adults in an earlier Phase 2 study, including a fast onset of protection.

Emergent BioSolutions Finalizes Sale of Travel Health Business to Bavarian Nordic

Retrieved on: 
Monday, May 15, 2023
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GAITHERSBURG, Md., May 15, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions (NYSE: EBS) today announced it has completed the sale of its travel health business to Bavarian Nordic (OMX: BAVA).

Key Points: 
  • GAITHERSBURG, Md., May 15, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions (NYSE: EBS) today announced it has completed the sale of its travel health business to Bavarian Nordic (OMX: BAVA).
  • At closing Emergent received $270 million, subject to customary closing adjustments, and may receive up to an additional $110 million in potential future milestone payments.
  • Bavarian Nordic also acquired manufacturing facilities in Bern, Switzerland, and development facilities in San Diego, California.
  • The majority of Emergent employees supporting these products and facilities are joining Bavarian Nordic.